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Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 52321...

FDA Device Recall #Z-2181-2025 — Class I — July 9, 2025

Recall Summary

Recall Number Z-2181-2025
Classification Class I — Serious risk
Date Initiated July 9, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ambu Inc.
Location Columbia, MD
Product Type Devices
Quantity 87,156 units

Product Description

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus

Reason for Recall

Potential for the manometer port being blocked rendering the manometer non-functional.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Lot / Code Information

1. Catalog Number: 523211000; UDI Number: 05707480152193; Lot Numbers: 1001113554, 1001118764. 2. Catalog Number: 523611051; UDI Number: 05707480149513; Lot Numbers: 2000015874. 3. Catalog Number: 523611057; UDI Number: 05707480038688; Lot Numbers: 2000015876. 4. Catalog Number: 524611000; UDI Number: 05707480152278; Lot Numbers: 1001110297. 5. Catalog Number: 524611001; UDI Number: 05707480149698; Lot Numbers: 2000015881. 6. Catalog Number: 524611011; UDI Number: 05707480149711; Lot Numbers: 2000015882. 7. Catalog Number: 524611031; UDI Number: 05707480149735; Lot Numbers: 2000015884, 2000015968. 8. Catalog Number: 524611047; UDI Number: 05707480149759; Lot Numbers: 2000016102. 9. Catalog Number: 524611051; UDI Number: 05707480154395; Lot Numbers: 2000015969, 2000016252. 10. Catalog Number: 530200016; UDI Number: 05707480149773; Lot Numbers: 2000014933, 2000015857. 11. Catalog Number: 530212000; UDI Number: 05707480152353; Lot Numbers: 1001113557. 12. Catalog Number: 530212001; UDI Number: 05707480149797; Lot Numbers: 2000016408. 13. Catalog Number: 530213000; UDI Number: 05707480152377; Lot Numbers: 1001110299, 1001113558, 1001118767, 1001106634. 14. Catalog Number: 530213001; UDI Number: 05707480152391; Lot Numbers: 1001106635. 15. Catalog Number: 530213011; UDI Number: 05707480152438; Lot Numbers: 1001118768. 16. Catalog Number: 530213030; UDI Number: 05707480149858; Lot Numbers: 2000016409. 17. Catalog Number: 530213031; UDI Number: 05707480152452; Lot Numbers: 1001113560, 1001118769. 18. Catalog Number: 530213048; UDI Number: 05707480154159; Lot Numbers: 2000016529, 2000016410. 19. Catalog Number: 530214000; UDI Number: 05707480152490; Lot Numbers: 1001106636, 1001113561. 20. Catalog Number: 530613000; UDI Number: 05707480152612; Lot Numbers: 1001110301, 1001121455, 1001106637, 1001118771. 21. Catalog Number: 530613031; UDI Number: 05707480150212; Lot Numbers: 2000015889. 22. Catalog Number: 530613071; UDI Number: 05707480150298; Lot Numbers: 2000015574. 23. Catalog Number: 530613831; UDI Number: 05707480150373; Lot Numbers: 2000015179, 2000015726, 2000015891. 24. Catalog Number: 530614017; UDI Number: 05707480150397; Lot Numbers: 2000015440. 25. Catalog Number: 530614030; UDI Number: 05707480150410; Lot Numbers: 2000014938, 2000015299. 26. Catalog Number: 530614800; UDI Number: 05707480150434; Lot Numbers: 2000015098. 27. Catalog Number: 530615030; UDI Number: 05707480150472; Lot Numbers: 2000015893. 28. Catalog Number: 530619031; UDI Number: 05707480150595; Lot Numbers: 2000016761. 29. Catalog Number: 531600051; UDI Number: 05707480163441; Lot Numbers: 2000015181, 2000015577. 30. Catalog Number: 531613000; UDI Number: 05707480152773; Lot Numbers: 1001118773, 1001121460, 1001106640. 31. Catalog Number: 531613001; UDI Number: 05707480152797; Lot Numbers: 1001106641, 1001110305, 1001113567, 1001118774. 32. Catalog Number: 531613010; UDI Number: 05707480152810; Lot Numbers: 1001113568. 33. Catalog Number: 531613031; UDI Number: 05707480150717; Lot Numbers: 2000015182, 2000015731, 2000015896, 2000016112, 2000016263. 34. Catalog Number: 531613047; UDI Number: 05707480150755; Lot Numbers: 2000015444, 2000015580, 2000015897, 2000015982. 35. Catalog Number: 531613051; UDI Number: 05707480154470; Lot Numbers: 2000016825. 36. Catalog Number: 531614026; UDI Number: 05707480150854; Lot Numbers: 2000016265, 2000016612. 37. Catalog Number: 531638000; UDI Number: 05707480150878; Lot Numbers: 2000015184, 2000015583. 38. Catalog Number: 523611051E; UDI Number: 05707480154135; Lot Numbers: 2000015292, 2000015559, 2000016401. 39. Catalog Number: 530213000B; UDI Number: 05707480153534; Lot Numbers: 1001113559

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Z-1723-2025 Class II Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. ... Apr 7, 2025
Z-0261-2025 Class II Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR... Sep 16, 2024
Z-0714-2024 Class II Ambu aView 2 A Monitor, Catalog numbers 4050110... Dec 5, 2023
Z-2628-2023 Class II Ambu aView 2 A Monitor-The Ambu aView 2 Advance... Jul 21, 2023
Z-1420-2022 Class II Ambu VivaSight 2 DLT; endobronchial tube system... Jun 3, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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